Postpartum Pelvic Floor Workshop

Pelvic Floor Disorders Clinical Trial

— PPFW  

Official title:

A Randomized Trial: Can a Postpartum Pelvic Floor Education Workshop in a High-Risk Population Improve Pelvic Floor Symptoms?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04754984
• Other study ID #: 2020-10672
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: March 20, 2023

Study information

• Verified date: January 2024
• Source: Hamilton Health Sciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

After having a baby, there are some expected changes in pelvic floor function. However, tearing of the pelvic floor, having a large baby and needing a vacuum or forceps to deliver the baby put women at risk for having pelvic floor disorders. Our study aims to see if, in women who had a high risk for pelvic floor disorders, a pelvic floor education workshop four weeks after delivery can improve pelvic floor disorders compared to those that did not have a workshop.

Description:

There is compelling evidence for the need for perineal education and care, especially in women who have recognized risk factors. For example, 30-50% of women who have a clinically recognized risk factor report anal incontinence, fecal urgency, dyspareunia and perineal pain. Despite this, a study found that less than 50% of women with anal incontinence voice those symptoms unless directly asked about them.

Some authors discuss how women may not share these symptoms with their care providers out of the belief that it is a "normal" effect of childbirth. A review of the literature shows that antenatal educational workshops can be an effective means to provide pregnant women with information regarding pelvic floor health, including how modes of delivery impact pelvic floor function. Similarly, antenatal pelvic floor workshops have been found to improve patients' knowledge on pelvic floor health, their practice of pelvic floor muscle exercises and their confidence with these exercises.

To our knowledge, there is no literature exploring the role of a postpartum pelvic floor workshop, on managing perineal and pelvic floor symptoms in women who are identified as being at higher risk of developing pelvic floor dysfunction. Our goal is to develop and assess such a workshop.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 20, 2023
• Est. primary completion date: March 20, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Postpartum (ie no more than 4 weeks postpartum at time of group allocation)

• Vaginal delivery

• Sustained one or more of the following insults to perineum/pelvic floor

• Third or fourth degree laceration

• Vacuum or forceps assisted vaginal delivery

• Delivery of macrosomic infant =4000g)

Exclusion Criteria:

• Prior pelvic floor physiotherapy treatment

• Prior surgical management for pelvic organ prolapse or incontinence

• Unable to understand English

• Caesarean delivery

• Concerns for patient sensitivity - eg if team is aware of neonatal demise, neonate unwell in NICU etc

Related Conditions & MeSH terms

• Muscle Weakness
• Pelvic Floor Disorders
• Pelvic Floor Muscle Weakness
• Pelvic Floor; Incompetency
• Perineum; Injury

Intervention

Behavioral:
• Pelvic floor workshop
Physiotherapist-led workshop on managing pelvic floor symptoms

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences	Hamilton	Ontario
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pelvic floor distress inventory	Survey on symptoms of pelvic floor distress	Differences between groups in the change in score from beginning of study to 3 months post-partum
Primary	Pelvic floor distress inventory	Survey on symptoms of pelvic floor distress	Differences between groups in the change in score from beginning of study to 6 months post-partum
Primary	Pelvic floor distress inventory	Validated survey on symptoms of pelvic floor distress	Differences between groups in the change in score from beginning of study to 12 months post-partum
Secondary	Adherence to pelvic floor exercises	Investigator generated questions; Difference between groups in proportion who reported adherence to pelvic floor exercises	From beginning of study to 12 months post-partum
Secondary	Seeking medical care for pelvic floor symptoms	Investigator generated questions: Difference between groups in proportion who reported seeking medical care for their symptoms	from beginning of study to 12 months post-partum.